Study of the 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte
This study is ongoing, but not recruiting participants.
Sponsor:
Cutera Inc.
Information provided by (Responsible Party):
Cutera Inc.
ClinicalTrials.gov Identifier:
NCT01491620
First received: December 5, 2011
Last updated: August 7, 2012
Last verified: August 2012
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Purpose
This study will evaluate the safety and efficacy of the Excel V 532 nm KTP laser for the treatment of dyschromia of the neck and/or chest (poikiloderma of Civatte).
| Condition | Intervention |
|---|---|
|
Poikiloderma of Civatte Dyschromia Pigmentation Disorders Telangiectasia Photosensitivity Disorders |
Device: 532 nm KTP laser |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Single-Center Prospective, Open-Label Study of the Excel V 532 nm KTP Laser for the Treatment of Poikiloderma of Civatte |
Resource links provided by NLM:
Genetics Home Reference related topics:
pyridoxal 5'-phosphate-dependent epilepsy
MedlinePlus related topics:
Skin Pigmentation Disorders
U.S. FDA Resources
Further study details as provided by Cutera Inc.:
Primary Outcome Measures:
- Severity Assessment Score [ Time Frame: 24 weeks post final treatment ] [ Designated as safety issue: No ]Change in physician's Severity Assessment score based on blinded assessment of subject photographs by a panel of independent dermatologists.
- Physician's Global Assessment (Blinded) [ Time Frame: 24 weeks post final treatment ] [ Designated as safety issue: No ]Before and after subject photographs will be presented to a panel of independent dermatologists. The panel will be blinded to treatment parameters and the photograph time point. Each dermatologist will be asked to select the baseline photograph and then rate improvement in poikiloderma of Civatte in the post-treatment photograph using a 5-point improvement scale.
Secondary Outcome Measures:
- Physician's Global Assessment [ Time Frame: 12 and 24 weeks post final treatment ] [ Designated as safety issue: No ]Investigator will assess improvement in poikiloderma of Civatte as compared to baseline using a 5-point improvement scale.
- Severity Assessment Score [ Time Frame: 12 and 24 weeks post final treatment ] [ Designated as safety issue: No ]Investigator will perform Severity Assessment of the subject's poikiloderma of Civatte.
- Subject's Global Assessment [ Time Frame: 12 and 24 weeks post final treatment ] [ Designated as safety issue: No ]Subjects will assess improvement of poikiloderma of Civatte as compared to baseline using a 5-point improvement scale.
- Subject Satisfaction Assessment [ Time Frame: 12 and 24 weeks post final laser treatment ] [ Designated as safety issue: No ]Subjects will assess overall satisfacion with improvement of poikiloderma of Civatte and proceedure using a 5-point satisfaction scale.
- Spectrophotometer Measurement [ Time Frame: 12 and 24 weeks post final laser treatment ] [ Designated as safety issue: No ]Change in pigmentation and erythema as assessed by spectrophotometer measurements as compared to baseline.
- Assessment of Adverse Events [ Time Frame: 24 weeks post final laster treatment ] [ Designated as safety issue: Yes ]Incidence and severity of all procedure-related adverse events.
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 532 nm KTP laser treatment |
Device: 532 nm KTP laser
Two laser treatment sessions, 6 weeks apart.
Other Name: Excel V
|
Eligibility| Ages Eligible for Study: | 35 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Fitzpatrick Skin Type I - III
- Clinical diagnosis of poikiloderma of Civatte affecting the neck and/or chest
- Willing to refrain from using topical corticosteroids, retinoids and bleaching agents on the treated area
- Agree not to undergo any other procedure for the treatment of poikiloderma of Civatte during the study
- Willing and able to read, understand and sign the Informed Consent Form
- Willing and able to adhere to the treatment and follow-up schedule and post-treatment care instructions
Exclusion Criteria:
- Any laser treatment on neck and/or chest within 12 months
- Any topical treatment on neck and/or chest within 6 months
- Pregnant and/or breastfeeding
- Infection, dermatitis or a rash in the treatment area
- Suffering from significant concurrent illness, such as Diabetes Mellitus or pertinent neurological disorders
- History of seizure disorders due to light, fibromyalgia, connective tissue disease, vitiligo, psoriasis, pigmentary disorders, keloid scarring, hypertrophic scarring or abnormal wound healing
- History of immunosuppression/immune deficiency disorders or currently using immunosuppressive medications
- Having a known anticoagulative condition or taking anticoagulation medications
- History of diseases stimulated by heat, unless treatment is conducted following a prophylactic regimen
- Having undergone any surgery in the treatment area within 6 months of treatment (or more if skin has not healed completely)
- History of radiation to the head, neck and/or upper chest
- Undergoing systemic chemotherapy for the treatment of cancer
- Systemic use of isotretinoin (Accutane®) within 6 months
- Any use of gold therapy
- Excessively tanned in areas to be treated or unable/unlikely to refrain from tanning during the study
- Current smoker or history of smoking within 12 months of study
- Participation in a study of another device or drug within 6 months
- As per the Investigator's discretion, any physical or mental condition which might make it unsafe for the subject to participate in study
Contacts and Locations More Information
No publications provided
| Responsible Party: | Cutera Inc. |
| ClinicalTrials.gov Identifier: | NCT01491620 History of Changes |
| Other Study ID Numbers: | C-11-XPC01 |
| Study First Received: | December 5, 2011 |
| Last Updated: | August 7, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cutera Inc.:
|
poikiloderma of Civatte red dyschromia brown dyschromia sun damage neck chest dyschromia |
pigmentation disorders erythema photosensitivity disorders sun exposure telangiectasia hyperpigmentation hypopigmentation |
Additional relevant MeSH terms:
|
Photosensitivity Disorders Telangiectasis Pigmentation Disorders Dermatitis, Phototoxic Epilepsy, Reflex Skin Diseases Vascular Diseases Cardiovascular Diseases |
Dermatitis, Irritant Dermatitis, Contact Dermatitis Skin Diseases, Eczematous Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013